Agenda at a Glance

8:10 a.m. – 8:50 a.m. | Innovation in Medical Devices—From Starships to Biomicroelectronics to Cure BlindnessDamien C. Rodger, MD, PhD, Assistant Professor of Ophthalmology, University of Southern California & Visiting Associate in Medical Engineering, California Institute of Technology [Bio] Parylene C is a USP class VI biocompatible polymer that has been used for decades as a coating in biomedical devices due to its many attractive properties including high flexibility, pinhole free conformality, and low water permeability. Recently, the focus has been on using parylene as a structural material for devices and not just as a coating. The goal has been to apply parylene to the field of ophthalmology, first as an ideal material for high-density retinal stimulation electrode arrays and radiofrequency power and data coils, as well as a packaging material, for intraocular retinal prostheses. We have also used parylene as the main structural material for intraocular pressure sensors, glaucoma drainage devices, drug delivery devices, and now as a substrate for retinal pigment epithelium derived from human embryonic stem cells for the treatment of blinding eye diseases. Finally, we have shown that we can stimulate the spinal cord in cases of spinal cord injury to allow stepping and standing. In this presentation, hear about the transformation of these ideas from the design stage into microfabrication runs to testing, a process the speaker was initially exposed to while working at NASA. The presentation will additionally focus on the intellectual property and technology transfer process with a drive toward ultimate commercialization in the highly competitive academic setting.

8:50 a.m. – 9:05 a.m. | PLM Vignette: Alcon Laboratories Journey to a Single Product Quality Management SystemMark Turner, Senior Technical Manager – Development IT, Alcon Laboratories R&D Portfolio & Product Lifecycle, Novartis Services, Inc.[Bio] When the Vision Care and Intraocular Cataract Lenses businesses at Alcon Laboratories (Alcon) needed to find a solution for managing their design control process and laboratory test results and sample tracking, the R&D, Quality, and Regulatory teams looked to PTC Windchill to meet their requirements. Since Alcon designs and manufactures a variety of medical devices, they are required to follow Part 820 of CFR Title 21 regulation and to maintain documentation supporting the 820.30 Design Controls subpart. Alcon was already using PTC Windchill for CAD data management and decided that PTC Windchill was a great fit for managing their design control process and related deliverables as a part of their journey to a single solution for product quality management.

9:05 a.m. – 9:35 a.m. | Major Trends in Innovation 2016 and BeyondDr. Suna Polat, Director, Collaborative Innovation & Social Product Development Consulting Practice, CIMdata [Bio] Sustaining profitable business growth is difficult for established enterprises in today’s networked economy. Good ideas can emerge from anywhere, and the next big competitor could even be a start-up. In this environment, enterprises must reevaluate their approach to innovation. Many are aware that they are suffering from inefficiencies in their innovation process due to disjointed processes and the tools they have adopted over the years. At the same time, they seem to be slower to invest in new Enterprise Innovation Management (EIM) solutions that can provide competitive advantages. CIMdata conducted research to understand and address existing concerns and preempt the emerging concerns of industrial firms engaged in innovation but that are confused and hesitant to invest in new EIM solutions. This presentation will share the results of this research including a clearly defined terminology and an innovation system framework, that includes solutions, benefits, implementation strategies, and challenges.

9:35 a.m. – 10:05 a.m. | Networking Break & PLM Collaboration Café

10:05 a.m. – 10:40 a.m. | Enterprise PLM - A Global Compliance ImperativeDavid Sherburne, Executive Director, IT, Carestream Health Inc. [Bio] As companies continue to globalize engineering and manufacturing, the appropriate establishment and maintenance of several critical baselines are required for maintaining medical device compliance. This presentation will show how a harmonized enterprise PLM platform is in the best position to provide a global master data repository for key quality baselines.

10:40 a.m. – 10:55 a.m. | PLM Vignette: IoT and the Business of Engineering Marc Lind, SVP of Global Marketing, Aras[Bio] The push for Internet of Things (IoT) enablement is driving a tidal wave of change at companies to support new business models, value propositions, and customer experiences. Sophisticated designs and connectivity are bringing together software, electronics, and hardware in complex new ways to create tremendous opportunities along with far greater risks of quality problems, time-to-market delays, and the potential for serious compliance and liability issues. In this vignette find out how new PLM platform approaches are being used to address these challenges and propel the digital transformation in product development.

10:55 a.m. – 11:30 a.m. | Big Bang Commitment to Go-LiveGail Bakewell, Program Manager, Edwards Lifesciences [Bio]Gail Edwards will present the readiness preparation and organization support required to support a Big Bang PLM roll out to a 2,000+ user global population. This presentation will address program governance, business community participation, training and communication approach, count-down to go-live, and post go-live Hyper Care support.

11:30 a.m. – 11:45 a.m. | PLM Vignette: Overview: Engineering the IoT for HealthCareVic Kulkarni, General Manager, ANSYSThis presentation will take a look at medical device technology trends and challenges and will emphasize the importance of simulation-driven product design to the industry.

11:45 a.m. – 12:20 p.m. | A Cool Treatment for Cancer Pain - Computer Modeling of Transport Phenomena in RF Ablation ApplicationDr. Adriana Druma, Thermal Systems Engineer, Aavid Thermalloy [Bio]One of the most common causes for severe pain in patients with cancer comes from cancer metastases. Once the cancer has metastasized, the patients often experience chronic pain or other related effects (SRE). Even though radiotherapy and chemotherapy is the standard of care for cancer patients, approximately 25% of those patients do not get pain relief. There are currently several treatment options for painful metastatic disease with RF ablation being the most mature treatment option. Learn how a multiphysics simulation was used to model a water-cooled RF applicator used in the OsteoCool Ablation System and how applicator designs were modeled in order to understand the physics behind lesion formation and provide a platform for the new device design.

12:20 p.m. – 1:40 p.m. | Networking Lunch & PLM Collaboration Café

1:40 p.m. – 2:15 p.m. | PLM: Enabling the Materials AgePeter Bilello, President, CIMdata, Inc. [Bio]Many would argue that we are in the Information Age, which has brought us the tools, techniques, and processes in PLM that support the way we define, design, engineer, produce, and support products. Over the years, engineers have learned how to encode mathematics and physics in analytical programs that can accurately predict how things will work in the real world. Materials handbooks summarize this information, so that engineers and designers can pick materials with a high degree of confidence, and design components using them that will function as predicted. Using materials like plastics, ceramics, and composites in new applications and compositions required the development of new methods, analytics, testing, and other skills to ensure that these materials function as required. This presentation will describe the next age—the Materials Age—and how PLM and PLM practitioners will need to evolve to enable it.

2:15 p.m. – 2:30 p.m. | PLM Vignette:The Future of Making Things: Harnessing Innovation to Stay AheadRoss Millenacker, Product Manager, Fusion Lifecycle & Vault Industry Strategy & Marketing, Autodesk[Bio]
Massive disruption in the way products are designed, made, and used is forcing companies to re-think their approach to innovation - transforming the way they do business. Autodesk is helping Manufacturing customers thrive in this dynamic environment with a cloud-based Product Innovation Platform, in which PLM is a cornerstone piece. Coupled with Configure Price Quote (CPQ) and Internet of Things (IoT) solutions, Autodesk’s approach to PLM is unlocking new sources of value for Manufacturers in the High Tech and Medical fields.

2:30 p.m. – 3:05 p.m. | Panel Discussion: What's Holding the Industry Back? What is Limiting the High Tech and Medical Device Vision for the Adoption of PLM?Facilitated by Laila Hirr, Practice Manager, High Technology Electronics, CIMdata [Bio]In this panel discussion about the maturity levels of PLM usage in the High Tech and Medical Device industries you will learn more about the evolution of PLM adoption in these industries and the options that are available to close perceived technology gaps.

3:05 p.m. – 3:35 p.m. | Networking Break & PLM Collaboration Café

3:35 p.m. – 4:10 p.m. | Innovating Organizational Change Management with Enterprise DeploymentsSandeep Waghchoure, Director, Business Transformation Program Office, Dell [Bio] This presentation will share information about a complex cross-functional strategic initiative that was undertaken at Dell leveraging the 4 Disciplines of Execution methodology. The presentation will highlight how a breakthrough idea was propagated through a large organization in record time, aligning over 14 different functional groups and over 5,000 people—uniting them in a singular mission to improve Dell’s on-time delivery experience to its customers. The presentation will also share some key lessons learned which can be applied across a variety of areas and industries. A dialogue on transforming culture will be encouraged.

4:10 p.m. – 4:45 p.m. | Fostering Innovation and SerendipityLeo Baldwin, Principal Engineer, Amazon [Bio] Innovation is not only essential to win in today’s marketplace, it is essential to survive. To foster innovation, management must be able to spot innovators and understand how they may be different from other top performers, and why not all top performers are innovators. The contribution of failure and serendipity to innovation will be illustrated with an anecdote or two from the speaker’s own experience.